NDC 0067-8137

Theraflu ExpressMax Nighttime Severe Cold and Cough

Acetaminophen, Diphenhydramine Hcl, Phenylephrine Hcl

Theraflu ExpressMax Nighttime Severe Cold and Cough is a Oral Tablet, Film Coated in the Human Otc Drug category. It is labeled and distributed by Glaxosmithkline Consumer Healthcare Holdings (us) Llc. The primary component is Acetaminophen; Diphenhydramine Hydrochloride; Phenylephrine Hydrochloride.

• Product ID: 0067-8137_5201084d-a412-4c4f-b101-0432e97abd9f
• NDC: 0067-8137
• Product Type: Human Otc Drug
• Proprietary Name: Theraflu ExpressMax Nighttime Severe Cold and Cough
• Generic Name: Acetaminophen, Diphenhydramine Hcl, Phenylephrine Hcl
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2016-07-05
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part341
• Labeler Name: GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
• Substance Name: ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE
• Active Ingredient Strength: 325 mg/1; mg/1; mg/1
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 0067-8137-10

1 BLISTER PACK in 1 CARTON (0067-8137-10) > 10 TABLET, FILM COATED in 1 BLISTER PACK

• Marketing Start Date: 2017-06-08
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0067-8137-10 [00067813710]

Theraflu ExpressMax Nighttime Severe Cold and Cough TABLET, FILM COATED

• Marketing Category: OTC monograph final
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2017-06-08

NDC 0067-8137-20 [00067813720]

Theraflu ExpressMax Nighttime Severe Cold and Cough TABLET, FILM COATED

• Marketing Category: OTC monograph final
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Billing Unit: EA
• Marketing Start Date: 2016-07-05

Drug Details

Active Ingredients

Ingredient	Strength
ACETAMINOPHEN	325 mg/1

OpenFDA Data

• SPL SET ID: 62f7fcb9-e31a-4634-b1c2-44a9567e3a61
• Manufacturer:
  • GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
• UNII:
  • TC2D6JAD40
  • 362O9ITL9D
  • 04JA59TNSJ
• RxNorm Concept Unique ID - RxCUI:
  • 1233575

NDC Crossover Matching brand name "Theraflu ExpressMax Nighttime Severe Cold and Cough" or generic name "Acetaminophen, Diphenhydramine Hcl, Phenylephrine Hcl"

NDC	Brand Name	Generic Name
13411-839	AcetaFlu NightTime	Acetaminophen, Diphenhydramine HCl, Phenylephrine HCl
13411-841	AcetaFlu NightTime Effervescent	Acetaminophen, Diphenhydramine HCl, Phenylephrine HCl
41250-464	Allergy Plus Sinus Headache	Acetaminophen, Diphenhydramine HCl, Phenylephrine HCl
0363-5430	Allergy Relief	ACETAMINOPHEN, DIPHENHYDRAMINE HCl, PHENYLEPHRINE HCl
15127-862	Flu and Sore Throat	Acetaminophen, Diphenhydramine HCl, Phenylephrine HCl
36800-317	Flu Relief Therapy	Acetaminophen, Diphenhydramine HCl, Phenylephrine HCl
46122-016	Flu Relief Therapy	Acetaminophen, Diphenhydramine HCl, Phenylephrine HCl
15127-922	Flu Relief Therapy Nighttime	Acetaminophen, Diphenhydramine HCl, Phenylephrine HCl
46122-268	good neighbor pharmacy cold and flu night time	Acetaminophen, diphenhydramine HCl, phenylephrine HCl
46122-311	Nighttime Flu Relief Therapy	Acetaminophen, Diphenhydramine HCl, Phenylephrine HCl
11822-0543	Severe Allergy And Sinus Headache	Acetaminophen, Diphenhydramine HCl, Phenylephrine HCl
41250-543	Severe Allergy Plus Sinus Headache	Acetaminophen, Diphenhydramine HCl, Phenylephrine HCl
49035-543	Severe Allergy Plus Sinus Headache	Acetaminophen, Diphenhydramine HCl, Phenylephrine HCl
37808-017	Severe Cold and Cough Relief	Acetaminophen, Diphenhydramine HCl, Phenylephrine HCl
42507-317	Severe Cold and Cough Relief	Acetaminophen, Diphenhydramine HCl, Phenylephrine HCl
0067-6095	THERAFLU	ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL
0067-7918	THERAFLU	ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL
0067-8129	Theraflu ExpressMax	Acetaminophen, Diphenhydramine HCl, Phenylephrine HCl
0067-8131	Theraflu ExpressMax	Acetaminophen, Diphenhydramine HCl, Phenylephrine HCl
0067-8137	Theraflu ExpressMax	acetaminophen, diphenhydramine HCl, phenylephrine HCl
36800-999	topcare cold and flu night time	Acetaminophen, diphenhydramine HCl, phenylephrine HCl
36800-919	Topcare Tussin	Acetaminophen, diphenhydramine HCl, phenylephrine HCl
36800-902	topcare tussin cf max	Acetaminophen, diphenhydramine HCl, phenylephrine HCl
0363-0543	Wal-Dryl	Acetaminophen, Diphenhydramine HCl, Phenylephrine HCl